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Allergen-Specific Immunotherapy

Viaskin Peanut for Peanut Allergy (VITESSE Trial)

Phase 3
Recruiting
Research Sponsored by DBV Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening up to month 14
Awards & highlights

VITESSE Trial Summary

This trial tests if a daily dose of a drug can help children with peanut allergies become less sensitive to it over a year.

Who is the study for?
This trial is for peanut-allergic children aged 4-7 who react to a very small amount of peanut protein and are on a strict peanut-free diet. They must have certain levels of peanut-specific antibodies and skin test reactions. Kids with uncontrolled asthma, past immunotherapy for peanuts, or recent biologic treatments can't join.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of DBV712 (250 mcg), a daily treatment aimed at desensitizing children to peanuts over one year. The comparison is made against a placebo—a substance with no active drug—to see if DBV712 makes any difference.See study design
What are the potential side effects?
Possible side effects include local skin reactions where the patch is applied, such as redness or itching. There may also be systemic allergic responses due to exposure to the allergen in the treatment.

VITESSE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening up to month 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening up to month 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Treatment Responders in the DBV712 Group Compared to Placebo Group
Secondary outcome measures
Cumulative Reactive Dose (CRD) of Peanut Protein
Eliciting Dose (ED) of Peanut Protein
Number of Participants by Maximum Severity of Allergic Reaction During the Peanut Oral Food Challenge
+1 more
Other outcome measures
Number of Participants With Systemic Allergic Reactions
Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESI)
Total Score for Scoring Atopic Dermatitis (SCORAD)

VITESSE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DBV712 250 mcgExperimental Treatment1 Intervention
Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).
Group II: PlaceboPlacebo Group1 Intervention
Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).

Find a Location

Who is running the clinical trial?

DBV TechnologiesLead Sponsor
16 Previous Clinical Trials
2,922 Total Patients Enrolled

Media Library

DBV712 (Allergen-Specific Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05741476 — Phase 3
Peanut Allergy Research Study Groups: DBV712 250 mcg, Placebo
Peanut Allergy Clinical Trial 2023: DBV712 Highlights & Side Effects. Trial Name: NCT05741476 — Phase 3
DBV712 (Allergen-Specific Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05741476 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment being opened to individuals below the age of 45 for this experiment?

"This research is open to children aged between 4 and 7 years of age."

Answered by AI

Does DBV712 250 mcg present any health risks to individuals?

"DBV712 250 mcg has been clinically evaluated for safety, and thus received a rating of 3. This signifies that the drug is in its third phase of testing with supporting evidence from previous trials to back up efficacy and side effect prevention or management."

Answered by AI

To what extent is the capacity of this medical research limited?

"Indeed, the published information on clinicaltrials.gov attests that this research is actively enrolling participants. First made available on March 15th 2023, it seeks 600 volunteers from 49 medical sites."

Answered by AI

Is there an opportunity to partake in this clinical study?

"This clinical trial is seeking 600 children aged between 4 and 7 who have been diagnosed with a peanut allergy. Participants must present an IgE level of more than 0.7 kUA/L, demonstrate a positive response to the skin prick test (SPT) with 6mm or greater in wheal diameter, and elicit an elicited dose (ED) of 100mg peanut protein during screening double blind placebo control food challenges (DBPCFC)."

Answered by AI

Is there an opportunity for more individuals to join this trial?

"Data on clinicaltrials.gov verifies that this research endeavour is actively seeking out participants - the initial posting was made on March 15th 2023 and a recent update took place one day prior."

Answered by AI

How many different sites are offering this clinical trial?

"Currently, this trial is operational at 49 sites spanning from Tucson to Los Angeles. To reduce travel-related issues, it's advantageous for prospective participants to pick a nearby location."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
DBV Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
2023. "Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05741476.
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